Clinical TrialAug 12, 2026, 09:39 AM
NeOnc NEO100 Phase 2a Meets Primary Endpoint; 48.9% PFS, 26.09-mo OS
AI Summary
NeOnc Technologies announced positive Phase 2a clinical trial results for its intranasal drug NEO100 in recurrent IDH1-mutant high-grade glioma. The study met its primary endpoint with a six-month progression-free survival rate of 48.9%, significantly exceeding the 20% benchmark (p=0.0047). The company also reported a median overall survival of 26.09 months and a favorable safety profile with no major toxicities. NeOnc plans to request a Type B meeting with the FDA to discuss a registrational development path for NEO100.
Key Highlights
- NEO100 Phase 2a met primary endpoint with 48.9% 6-month PFS.
- Six-month PFS significantly exceeded 20% benchmark (p=0.0047).
- Median overall survival was 26.09 months.
- 86.7% of patients alive at 6 months, 54.1% at 24 months.
- No major toxicities reported; adverse events were low-grade.
- Company to request FDA Type B meeting for registrational path.
- 5 of 24 patients remained on treatment.
- Objective response rate was 8.3% (2 of 24 patients).
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